Senior Manager, Regulatory Affairs

Recordati; Bridgewater (MA); On-site; USD 80,000 - 130,000; Full time

Job summary

Join an innovative pharmaceutical company dedicated to improving the lives of patients with rare diseases. This role focuses on managing regulatory affairs for high-impact therapies, ensuring compliance with FDA and Health Canada regulations, and contributing to life cycle management strategies. You'll work in a dynamic environment that fosters professional growth while making a significant impact on underserved communities. If you're passionate about regulatory affairs and want to be part of a mission-driven team, this opportunity is perfect for you.

Qualifications

• 6-8 years of experience in Regulatory Affairs with managerial experience.
• Strong project management skills and ability to manage multiple submissions.

Responsibilities

• Manage Regulatory Affairs Lifecycle Management for assigned products.
• Implement regulatory strategies and liaise with health authorities.

Skills

Regulatory Affairs

Project Management

Pharmacovigilance

Knowledge of FDA Regulations

Knowledge of Health Canada Regulations

Veeva Platform

Education

Bachelor's Degree

Advanced Degree in Life Sciences

Tools

Veeva

Job description

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.

At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.

This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.

Recordati. Unlocking the full potential of life.

This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati.

Recordati Rare Diseases, Inc. (RRD) develops high-impact therapies for devastating rare diseases, focusing on providing often overlooked treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, improved diagnoses, and enhanced treatment availability, covering endocrinology, metabolic, and oncology franchises. RRD is dedicated to excellence, fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives.

Reporting Structure

Reports To: Senior Director, RA, Strategy and LCM
Direct Reports: RA Specialist/Manager
Areas Managed: Regulatory Affairs Lifecycle Management

Overview

Manage RRD Regulatory Affairs Lifecycle Management for assigned products across multiple therapeutic areas for US and Canada, including contribution and implementation of the overall regulatory strategy, preparation of regulatory submissions and interface with relevant health authorities.

Essential Duties and Responsibilities

• Provide input to the regulatory strategy for life cycle management in US and Canada.
• Implement regulatory strategies supporting lifecycle management for US and Canada.
• Review documentation and prepare lifecycle management submissions.
• Liaise with regulatory authorities as needed pertaining to product lifecycle management.
• Oversee submission of advertising and promotional material to the FDA as required.
• Support the labeling and/or change control processes to ensure timely and comprehensive review.
• Maintain labels/labeling for newly acquired and existing products in compliance with regulatory requirements and company standards.
• Track Annual Report and Periodic Safety Update Reports (PSUR) schedules to ensure that required dossiers are prepared and submitted as required.
• Coordinate with Medical Affairs & Pharmacovigilance to ensure timely reporting of safety data to regulatory agencies and partners.
• Ensure compliance with all federal regulations regarding post-marketing reporting to the FDA and other health authorities.
• Supervise and train direct reports as applicable.
• Act in full compliance with all laws, regulations, and policies including adverse events / pharmacovigilance responsibilities.
• Perform additional duties as may be assigned.

Knowledge and Skills

• Knowledge of current FDA and Health Canada regulations and guidances; and knowledge of and experience with pharmacovigilance and related drug safety reporting regulations.
• Ability to manage multiple priorities and regulatory submissions at different stages as required.
• Strong project management skills with proven ability to drive projects through to completion.
• Working knowledge of Veeva platform helpful but not required.

Education and Experience

• Bachelor’s degree required; advanced degree in the life sciences preferred.
• At least 6-8 years’ experience in Regulatory Affairs, with managerial experience.
• Experience in a commercial-stage organization required.
• Demonstrated ability to deliver quality results within a fast-paced, dynamic environment.

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Based upon job requirements, employee may be required at times to attend meetings including travel out of state over weekends and nights. Employee must be able to freely operate and travel by car and train/plane modes of transportation. Employee is required to have a valid driver’s license and means of transportation.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be able to fly via commercial air carrier. This is largely a sedentary role; however, the employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; talk and hear. Occasionally is required to lift and/or move light to moderate weight up to 25 lbs.

Location/Travel

• This position is located at RRD’s US headquarters in New Jersey.
• Approximately 10% travel (domestic and international) required.

FLSA Classification

This position is considered Exempt.

EEO Statement

It is the policy of Recordati Rare Diseases to provide equal employment opportunity (EEO) to all persons regardless of race, color, religion, sex, sexual orientation, gender identity, or national origin. Further, Recordati Rare Diseases will not discriminate on the basis of any characteristic protected by federal, state, or local law. Recordati Rare Diseases will provide reasonable accommodations for qualified individuals with disabilities.

Disclaimer

This job description is not designed to cover or contain a comprehensive listing of the activities, duties or responsibilities that may be required.

At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.

If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.